FDA Drug Application (087708) for DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE by ROXANE

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Application Number087708
Product Number001
FormSOLUTION;ORAL
Dosage0.025MG/5ML;2.5MG/5ML
Product Market Status Prescription
Therapeutic Equivalence Evaluation Code AA Products in conventional dosage forms not presenting bioequivalence problems
Reference Drug
Drug NameDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
Active IngredientATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE



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